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Trial record 27 of 146 for:    lupus AND Lupus Nephritis

Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT02453997
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
United Christian Hospital
Information provided by (Responsible Party):
Dr. Desmond Yat-Hin Yap, The University of Hong Kong

Brief Summary:
This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10, 12 hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months' intervals and also when clinically significant events occurred. The MPA levels will be correlated with clinical parameters and outcomes. Pharmacogenomics studies will also be carried out and correlated with MPA exposure and clinical outcomes.

Condition or disease
Lupus Nephritis

Detailed Description:
This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10, 12 hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months' intervals and also when clinically significant events occurred. The MPA levels will be correlated with clinical parameters and outcomes. For active patients, the MPA levels will be correlated with treatment response (CR or PR) and side effects. For patients in remission, the MPA levels will be correlated with drug tolerability and relapse. Pharmacogenomics studies will also be carried out and correlated with MPA exposure and clinical outcomes.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mycophenolic Acid Pharmacokinetics and Pharmacogenomics - Impact on the Clinical Outcomes of Patients With Severe Lupus Nephritis
Study Start Date : October 2012
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2019





Primary Outcome Measures :
  1. AUC (0-12) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Infection [ Time Frame: 24 months ]
  2. Gastrointestinal disturbances [ Time Frame: 24 months ]
  3. Complete or partial remission [ Time Frame: 24 months ]
  4. Relapse [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
EDTA blood samples for pharmacogenomics analysis


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Lupus Nephritis patients (both active or remission)
Criteria

Inclusion Criteria:

  1. Patients with recent active LN (biopsy-proven Class III/IV+/-V LN according to the ISN/RPS 2003 classifications within 3 months, with proteinuria >0.5 g/day and/or active urinary sediments) who receive corticosteroids and MMF (1g bd for 6 months) as induction treatment.
  2. LN patients in remission (defined as proteinuria <0.5 g/day with inactive urinary sediment, prednisolone <10 mg/day) and on stable MMF maintenance (dose unchanged within the previous 3 months).

Exclusion Criteria:

  1. Patients who receive enteric-coated mycophenolic acid (myfortic).
  2. Patients who receive concomitant calcineurin inhibitors (e.g. cyclosporine or tacrolimus) other than corticosteroids and MMF.
  3. Patients who receive concomitant medications which affect the MPA pharmacokinetics such as cholestyramine, acyclovir, and rifampicin.
  4. Patients who are pregnant or lactating.
  5. Patients with gastric emptying disorders
  6. Patients with hepatic or biliary diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453997


Contacts
Contact: Desmond Yap, MD 85222553879 desmondy@hku.hk

Locations
Hong Kong
Queen Mary Hospital, Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Desmond Yap, MD    85222553879    desmondy@hku.hk   
United Christian Hospital Recruiting
Hong Kong, Hong Kong
Contact: Ivan Tam    85235176677      
Sponsors and Collaborators
The University of Hong Kong
United Christian Hospital

Responsible Party: Dr. Desmond Yat-Hin Yap, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02453997     History of Changes
Other Study ID Numbers: UW12-462
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by Dr. Desmond Yat-Hin Yap, The University of Hong Kong:
lupus nephritis
mycophenolic acid
pharmacokinetics
pharmacogenomics

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Lupus Erythematosus, Systemic
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action